Off-label prosecutors target devices

In what may signal a new wave of government investigations, the US Attorney's Office in Philadelphia has issued a grand jury subpoena to a device firm— PA-based Synthes—over alleged off-label promotion practices.

Until now, off-label prosecutorial cases had been limited to drug makers. But prosecutors warned last October that their investigations were likely to spill over into the device arena.

HHS Office of the Inspector General senior counsel Jnatel Simmons says most government actions against medical device firms originate as qui tam actions or whistleblower lawsuits under the False Claims Act, which prohibits falsified claims for payment from being submitted to the government.